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Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00435019
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : December 8, 2009
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
Study Start Date : February 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: insulin detemir
insulin detemir + insulin aspart
Drug: insulin detemir
s.c. injection, once or twice daily.

Drug: insulin aspart
s.c. injection, at main meals.

Experimental: NPH insulin
NPH insulin + insulin aspart
Drug: insulin NPH
s.c. injection, once or twice daily.

Drug: insulin aspart
s.c. injection, at main meals.




Primary Outcome Measures :
  1. Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 52 weeks of treatment ]
    Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.


Secondary Outcome Measures :
  1. Number of Subjects Reporting Adverse Events [ Time Frame: from week -2 to week 52 ]

    Number of subjects reporting adverse events during the trial (from week -2 to week 52).

    For details, please refer to the adverse events section.


  2. Observed Insulin Antibody Values [ Time Frame: at 0 and 52 weeks ]
    Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin detemir naive
  • Type 1 diabetes for at least 12 months
  • HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

  • Significant concomitant diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435019


Locations
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Bulgaria
Novo Nordisk Investigational Site
Pleven, Bulgaria, 5800
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Novo Nordisk Investigational Site
Varna, Bulgaria, 9010
Czech Republic
Novo Nordisk Investigational Site
Olomouc, Czech Republic, 77520
Novo Nordisk Investigational Site
Pardubice, Czech Republic, 53203
Novo Nordisk Investigational Site
Prague 5, Czech Republic, 15018
Denmark
Novo Nordisk Investigational Site
Glostrup, Denmark, 2600
Novo Nordisk Investigational Site
Kolding, Denmark, 6000
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Viborg, Denmark, 8800
Finland
Novo Nordisk Investigational Site
Espoo, Finland, 02740
Novo Nordisk Investigational Site
Helsinki, Finland, 00029
Novo Nordisk Investigational Site
Oulu, Finland, 90029
Novo Nordisk Investigational Site
Seinäjoki, Finland, 60220
Novo Nordisk Investigational Site
Tampere, Finland, 33520
Novo Nordisk Investigational Site
Turku, Finland, 20100
France
Novo Nordisk Investigational Site
ANGERS cedex 09, France, 49033
Novo Nordisk Investigational Site
MONTPELLIER cedex 05, France, 34295
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Toulouse, France, 31059
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1083
Novo Nordisk Investigational Site
Miskolc, Hungary, 3501
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Poland
Novo Nordisk Investigational Site
Gdansk, Poland, 80-211
Novo Nordisk Investigational Site
Kielce, Poland, 25-734
Novo Nordisk Investigational Site
Siedlce, Poland, 08-110
Novo Nordisk Investigational Site
Warszawa, Poland, 00-576
Novo Nordisk Investigational Site
Warszawa, Poland, 01-184
Novo Nordisk Investigational Site
Warszawa, Poland, 04-730
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119049
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125373
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191144
Turkey
Novo Nordisk Investigational Site
Altunizade-Istanbul, Turkey, 34662
Novo Nordisk Investigational Site
Antalya, Turkey, 07059
Novo Nordisk Investigational Site
Istanbul, Turkey, 34093
Novo Nordisk Investigational Site
Izmir, Turkey, 35340
Novo Nordisk Investigational Site
Kayseri, Turkey, 38010
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 2ZG
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00435019    
Other Study ID Numbers: NN304-1689
2006-000051-18 ( EudraCT Number )
First Posted: February 14, 2007    Key Record Dates
Results First Posted: December 8, 2009
Last Update Posted: March 10, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs